US Court of Appeals for the Federal Circuit affirmed the district court’s post-trial order denying GSK’s motion for judgment of noninfringement as a matter of law, GSK’s motion for a new trial on infringement, and GSK’s motion for a new trial on damages. And upheld the district court’s claim construction with respect to the “composite active particles” limitation in claim 3 of the US 8,303,991 (the ‘991) patent. The ‘991 patent concerns the production of “composite active particles” for use in pulmonary administration, such as in dry-powder inhalers.
GSK has 30 days to file a petition.
Background to litigation
Vectura and GSK had entered into an agreement in 2010 under which GSK had taken a license to formulation technology covered by a Vectura patent family. These licensed patents expired in July 2016. GSK had the option to license additional patent families under the original agreement but did not do so, resulting in the filing of the lawsuit by Vectura in 2016.
Vectura alleged direct infringement of claim 3 of the ‘991 patent. In May 2019, a jury found that GSK had wilfully infringed on the ‘991 patent, which covers several Ellipta products (Breo (fluticasone furoate and vilanterol), Anoro (umeclidinium and vilanterol), and Incruse (umeclidinium) DPIs used to treat airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema), and awarded Vectura $89.7 million in damages. In September 2019, a judge upheld that award and added another $10.5 million.
In addition to those amounts, GSK owes Vectura a 3% royalty on continuing sales of Breo, Anoro, and Incruse Ellipta DPIs, plus interest. Vectura estimates that the total amount could eventually reach $200 million.